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271 Pinto, P. (2006b) Difenoconazole technical (CGA169374) - subchronic neurotoxicity study in rats. Unpublished report No. PR1330-REG-R1 from Syngenta Crop Protection AG, Basel, Switzerland and Central Toxicology Laboratory (CTL), Cheshire, England. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Poth, A. (1989) Salmonella typhimurium reverse mutation assay with 1H-1,2,4-triazole. Unpublished report No. 158400 from Syngenta Crop Protection AG, Basel, Switzerland and Cytotest Cell Research GmbH & Co. KG, Rossdorf, Germany. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Procopio, K. & Hamilton, J. (1992) Acute toxicity range-finding study. Unpublished report No. 81R 057A from Novartis Crop Protection AG, Basel, Switzerland and Rohm and Haas, Philadelphia, USA. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Puri, E. (1986) CGA 131013 tech.: autoradiographic DNA repair test on rat hepatocytes. Unpublished report No. 860184 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Ltd, Basel, S witzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Renhof, M. (1988a) 1,2,4-Triazole - investigations into embryotoxic effects on rats after oral administration. Unpublished report No. 17401 from Novartis Crop Protection AG, Basel, Switzerland and Bayer AG T oxicological Institute, Wuppertal-Elberfeld, Germany. Submitted to WHO by Syngenta. Renhof, M. (1988b) 1,2,4-Triazole - investigations into embryotoxic effects on rats after oral administration. Unpublished report No. 17402 from Novartis Crop Protection AG, Basel, Switzerland and Bayer AG Toxicological Institute, Wuppertal-Elberfeld, Germany. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Richold, M., Allen, J.A., Williams, A. & Ransome, S.J. (1981) Cell transformation test for potential carcinogenicity of R152056. Unpublished report No. ICI 394A/81153 from Novartis Crop Protection AG, Basel, Switzerland and Huntingdon Research Centre Ltd, Huntingdon, England. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Rudzki, M.W., McCormick, G.C. & Arthur, A.T. (1988) CGA 169374 tech.: chronic toxicity study in dogs. Unpublished report No. MIN 862010 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Corp., Summit, USA. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Schoch, M. & Schneider, M. (1989) CGA 169374 tech.: 56-day feeding cataractogenicity in young chickens. Unpublished report No. 871210 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Ltd, Stein, Switzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Strasser, F. (1985) CGA 169374 tech.: chromosome studies on human lymphocytes in vitro. Unpublished report No. 850569 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Ltd, Basel, Switzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Strasser, F. (1986) CGA 131013 tech.: micronucleus test (Chinese hamster). Unpublished report No. 860185 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Ltd, Basel, Switzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Suter, P. (1986a) 28-Day cumulative oral toxicity (feeding) study with CGA 169374 in the rat. Unpublished report No. 040770 from Novartis Crop Protection AG, Basel, Switzerland and RCC Ltd, Itingen, S witzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Suter, P. (1986b) 13-Week oral toxicity (feeding) study with CGA 169374 in the rat. Unpublished report No. RCC 040757 from Novartis Crop Protection AG, Basel, Switzerland and RCC Ltd, Itingen, Switzerland. Submitted to WHO by Syngenta. Thevenaz, P. (1984) CGA 142856: acute oral LD 50 in the rat. Unpublished report No. 840887 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Ltd, Stein, Switzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Thevenaz, P. (1986) CGA 142856: 14-day subacute toxicity study in rats (dietary administration). Unpublished report No. 841140 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Ltd, Stein, Switzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. DIFENOCONAZOLE 201–272 JMPR 2007
272 Thomas, H. (1992) The effect of CGA 169374 tech. on selected biochemical and morphological liver parameters following subchronic administration to male mice. Unpublished report No. CB 91/15 from Novartis Crop Protection AG, Basel, Switzerland and Ciba-Geigy Ltd, Basel, Switzerland. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Thyssen, J. & Kimmerli, G. (1976) 1,2,4-Triazole occupational toxicology report. Unpublished report No. 5926 from Bayer AG, Leverkusen, Germany and Bayer AG Toxicological Institute, Wuppertal-Elberfeld, Germany. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. von, Keutz E. & Groening, P. (1984) THS 2212 (triazolylalanine): subchronic toxicity to dogs on oral administration. Unpublished report No. 12562 from Novartis Crop Protection AG, Basel, Switzerland and Bayer AG Toxicological Institute, Wuppertal-Elberfeld, Germany. Submitted to WHO by Syngenta Crop P rotection AG, Basel, Switzerland. Wahle, B.S. (2004a) A subacute toxicity testing study in the CD-1 mouse with 1,2,4-triazole. Unpublished report No. 200808 from Syngenta Crop Protection AG, Basel, Switzerland and Bayer Crop Science LP, Stilwell, USA. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Wahle, B.S. (2004b) A subchronic toxicity testing study in the CD-1 mouse with 1,2,4-triazole. Unpublished report No. 201052 from Syngenta Crop Protection AG, Basel, Switzerland and Bayer Crop Science LP, Stilwell, USA. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Wahle, B.S. & Sheets, L.P. (2004) A combined subchronic toxicity/neurotoxicity screening study in the Wistar rat with 1,2,4-triazole. Unpublished report No. 201024 from Syngenta Crop Protection AG, Basel, S witzerland and Bayer Crop Science LP, Stilwell, USA. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Watanabe, M. (1993) CGA 131013: DNA repair test (rec assay). Unpublished report No. IET 93-0010 from Novartis Crop Protection AG, Basel, Switzerland and the Institute of Environmental Toxicology, Tokyo, Japan. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Watkins, P. (1982) R152056: 3-(1,2,4-triazol-l-yl) alanine (ICI 156,342) – micronucleus test in CBC F1 mice. Unpublished report No. CTL/C/1164 from Novartis Crop Protection AG, Basel, Switzerland and Central Toxicology Laboratory (CTL), Cheshire, England. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Weber, H., Patzschke, K. & Wegner, L. (1978) 1,2,4-Triazole-14C - biokinetic studies on rats. Unpublished report No. 7920 from Brian Christen Companies, Inc., Minnetonka, USA. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland. Young, A. & Sheets, L.P. (2005) A two-generation reproductive toxicity study in the Wistar rat with 1,2,4-triazole. Unpublished report No. 201220 from Syngenta Crop Protection AG, Basel, Switzerland and Bayer Crop Science LP, Stilwell, USA. Submitted to WHO by Syngenta Crop Protection AG, Basel, S witzerland. DIFENOCONAZOLE 201–272 JMPR 2007
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Pesticide residues in food — 2007
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TABLE OF CONTENTS Page List of part
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Dr Vicki L. Dellarco, Office of Pes
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Abbreviations used 3-MC ACTH ADI ai
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MRL MS MS/MS MTD NMR NOAEC NOAEL NO
Page 14:
Introduction The toxicological mono
Page 18 and 19:
AMINOPYRALID First draft prepared b
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5 higher renal excretion in the gro
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7 Table 4. Recovery of radioactivit
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9 Table 7. Pharmacokinetic paramete
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11 (c) Exposure by inhalation Five
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13 Table 9. Acute toxicity of amino
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15 The data from urine analysis rev
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17 18, monthly for palpable masses.
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19 Table 12. Body weights of rats f
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21 Table 15. Results of assays for
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23 in both groups, feed consumption
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25 neurotoxicity after 12 months. B
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27 The same five time-mated NZW rab
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29 Mortality was increased in all g
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31 Levels relevant to risk assessme
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33 References Brooks, K.J. (2001a)
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35 Consulting, The Dow Chemical Com
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ATRAZINE First draft prepared by Ru
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39 in the early 1990s; this reflect
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41 Maximum concentrations in the bl
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43 In a study on comparative metabo
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45 Table 1. Metabolism of atrazine
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47 Figure 2. Proposed metabolic pat
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49 to intact skin; and that no read
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51 the highest dose, and food consu
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53 mice (evaluated as roughly equiv
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55 Table 5. Incidence of mammary tu
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57 Table 6. Selected findings from
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59 was decreased when compared with
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61 Table 9. Selected findings of a
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63 proestrus at the expense of days
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65 Table 10. Selected studies of ge
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67 End-point Test object Concentrat
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69 Table 12. Relevant findings in a
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73 respectively) and in males at th
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Page 92 and 93:
77 All dams survived until the end
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79 250 and 500 ppm. Body-weight gai
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81 In an assay for reverse mutation
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83 on pubertal development in femal
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85 parameters (decreased pH, specif
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Page 104 and 105:
89 0, 75, 150 or 300 mg/kg bw per d
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91 The NOAEL was 25 ppm, equal to 1
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93 In a study on the effect of atra
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95 Delayed parturition was seen at
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97 observed in the pair-fed group.
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99 examined, offspring in the atraz
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101 antagonize E2-induced luciferas
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103 increase in steroidogenesis is
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105 The immune system of adult mice
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107 In a later review of cancer epi
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109 In a 25-day study in rabbits tr
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111 developmental toxicity were 10
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113 regulation in male offspring in
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115 (d) Diaminochlorotriazine (DACT
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117 Developmental target/critical e
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119 • The failure to ovulate resu
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121 The relationship between increa
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123 Table A2. Comparison of paramet
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125 Ballantine, L., Murphy, T. G. &
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127 Dunkelberg, H., Fuchs, J., Heng
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129 Heneweer, M., van den Berg, M.
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131 Lindsay, L.A., Wimbert, K.V., G
Page 148 and 149:
133 Morseth, S.L. (1996d) Chronic (
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135 Rudzki, M.W., Batastina, G., &
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137 Tennant, A.H., Peng, B. & Klige
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AZINPHOS-METHYL First draft prepare
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141 methylation and oxidation of me
Page 158 and 159:
143 Table 1. Acute oral toxicity of
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145 Table 2. Cholinesterase activit
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147 at the highest dose. In both sp
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149 Table 6. Cholinesterase activit
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151 Table 8. Fertility of F 0 and F
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153 Table 10. Fertility parameters
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155 Groups of 22 mated Sprague-Dawl
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157 after completion of the feeding
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159 reduced motor activity in males
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161 sensitivity with that of labora
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163 measures to prevent worker expo
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165 when brain cholinesterase activ
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167 Critical end-points for setting
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169 Eiben, R., Schmidt, W., & Loese
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171 Myhr, B.C. (1983) Evaluation of
Page 188 and 189:
LAMBDA-CYHALOTHRIN First draft prep
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175 Figure 1. Chemical structures o
Page 192 and 193:
177 In a comparative study, the abs
Page 194 and 195:
179 Figure 2. Main pathways of biot
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181 (iv) Dermal sensitization In a
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183 observed in rats at the highest
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185 Mortality was not affected by t
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187 the group at 100 ppm, reduction
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189 and five females per group were
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191 10-12%) than those of controls
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193 Comments Biochemical aspects Or
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195 Toxicological evaluation Althou
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197 Metabolism in animals Toxicolog
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199 Harrison, M.P. (1984a) Cyhaloth
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DIFENOCONAZOLE First draft prepared
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203 a sex difference nor any marked
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205 demonstrated that the highest t
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207 Figure 3. Proposed metabolic pa
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209 of the study were unremarkable.
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211 Table 3. Results of studies of
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213 The no-observed-adverse-effect
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215 lower than those of rats in the
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217 hepatocellular enlargement. In
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219 i.e. males lost 15.4% and femal
Page 236 and 237: 221 and 357. This reduced food cons
Page 238 and 239: 223 There was very high mortality a
Page 240 and 241: 225 Table 6. Treatment-related hist
Page 242 and 243: 227 Rats Groups of 80 CRL:CD(SD)®
Page 244 and 245: 229 Table 7. Histopathology finding
Page 246 and 247: 231 D. Temporal association. The fe
Page 248 and 249: 233 2.5 Reproductive toxicity (a) M
Page 250 and 251: 235 t estes weights in the males at
Page 252 and 253: 237 continued to be lower than thos
Page 254 and 255: 239 Corpora lutea in each ovary wer
Page 256 and 257: 241 S1 + S2, not ossified — —
Page 258 and 259: 243 in the control group and in the
Page 260 and 261: 245 physically examined for changes
Page 262 and 263: 247 Table 16. Results of studies of
Page 264 and 265: 249 can occur in untreated mice, in
Page 266 and 267: 251 Study of reproductive toxicity
Page 272 and 273: 257 of the test article on microsom
Page 274 and 275: 259 Ophthalmoscopic examinations pe
Page 276 and 277: 261 the radioactivity was re-elimin
Page 278 and 279: 263 In a single-dose study of neuro
Page 280 and 281: 265 Estimate of acceptable daily in
Page 282 and 283: 267 Clapp, M.J.L., Killick, M.E., H
Page 284 and 285: 269 Herbold, B. (1983c) THS 2212 tr
Page 288 and 289: DIMETHOMORPH First draft prepared b
Page 290 and 291: 275 Five different treatment groups
Page 292 and 293: 277 To investigate the significance
Page 294 and 295: 279 and the E : Z isomer ratio was
Page 296 and 297: 281 Table 10. Tissue distribution o
Page 298 and 299: 283 (e) Dermal sensitization The de
Page 300 and 301: 285 females at the highest dose, to
Page 302 and 303: 287 The NOAEL was 10 mg/kg bw per d
Page 304 and 305: 289 concentrations in females were
Page 306 and 307: 291 health, moribundity and mortali
Page 308 and 309: 293 0-9%, mean, 3.5%; only one out
Page 310 and 311: Table 26. Organ weights adjusted to
Page 312 and 313: 297 cell hyperplasia. The testes tu
Page 314 and 315: 299 unscheduled DNA synthesis, the
Page 316 and 317: 301 Figure 3. Cumulative percentage
Page 318 and 319: 303 Rabbits In a dose-range finding
Page 320 and 321: 305 (b) Potentiation of hexobarbito
Page 322 and 323: 307 0.2% or less of the administere
Page 324 and 325: 309 eye-opening, pinna unfolding or
Page 326 and 327: 311 Lowest relevant inhalation NOAE
Page 328 and 329: 313 Gardner, J.R. (1989) CME 151 te
Page 330: 315 van de Waart, E.J. (1991b) Eval
Page 333 and 334: 318 Committee on Pesticide residues
Page 335 and 336: 320 (a) Ocular irritation Rabbits T
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322 weights were decreased in males
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324 toxicity was 5 mg/kg bw per day
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326 respectively; range for histori
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328 Table 4. Incidence of Leydig-ce
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330 and/or bilateral) was noted in
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332 No treatment-related signs of m
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334 Table 6. Incidence of selected
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336 or teratogenic potential at the
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338 and progesterone. The concentra
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340 the doses used in the 1-year st
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342 No neurotoxic effects were seen
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344 Lowest relevant reproductive NO
Page 361 and 362:
346 Keller, D.A. (1992c) Oncogenici
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PROCYMIDONE First draft prepared by
Page 366 and 367:
351 Rats Groups of five male and fe
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353 Table 1. Pharmacokinetic parame
Page 370 and 371:
355 Seven doses C max (µg equivale
Page 372 and 373:
357 Three groups of five male and f
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359 The excretion of radioactivity
Page 376 and 377:
361 Figure 1. Proposed metabolic pa
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363 water consumption were determin
Page 380 and 381:
365 finding. Histopathology reveale
Page 382 and 383:
367 The NOAEL was 500 ppm, equivale
Page 384 and 385:
369 The NOAEL was 100 mg/kg bw per
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371 at 2000 ppm. Histopathology rev
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373 b Each test was conducted in tr
Page 390 and 391:
375 experimental period. Rats were
Page 392 and 393:
377 hypospadias, testicular atrophy
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379 a single dose, which produced o
Page 396 and 397:
381 The anti-androgenic activities
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383 but only at 6000 ppm after 13 w
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385 The results are summarized in T
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387 males (all litters) in the grou
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389 procymidone (18-27% of the admi
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391 Procymidone induced liver tumou
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393 The Meeting concluded that the
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395 Toxicologically significant com
Page 412 and 413:
397 Harada, T. (1983) A review on m
Page 414 and 415:
399 Murakami, M., Yoshitake, A. & H
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401 Tarui, H. (2005b) In vitro meta
Page 419 and 420:
404 Explanation Profenofos is the I
Page 421 and 422:
406 The metabolism of ring-labelled
Page 423 and 424:
408 2. Toxicological studies 2.1 Ac
Page 425 and 426:
410 Rabbits Groups of two male and
Page 427 and 428:
412 Groups of five male and five fe
Page 429 and 430:
414 control group and in the test g
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416 of the rabbits at the highest d
Page 433 and 434:
418 The NOAEL for brain acetylcholi
Page 435 and 436:
420 Table 2. Histopathological find
Page 437 and 438:
422 1 out of 70; lowest dose, 3 out
Page 439 and 440:
424 body‐weight gains (3-10% decr
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426 treated groups for body-weight
Page 443 and 444:
428 (b) Short-term studies of neuro
Page 445 and 446:
430 represented as equally as possi
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432 pound and the equitoxic mixture
Page 449 and 450:
434 Inhibition of brain acetylcholi
Page 451 and 452:
436 Toxicological evaluation Erythr
Page 453 and 454:
438 Neurotoxicity/delayed neurotoxi
Page 455 and 456:
440 Harris, S.B. (1982) A teratolog
Page 457 and 458:
442 Puri, E. (1982a) Autoradiograph
Page 460 and 461:
PYRIMETHANIL First draft prepared b
Page 462 and 463:
447 Table 1. Excretion profile in r
Page 464 and 465:
449 Table 3. Half-life of pyrimetha
Page 466 and 467:
451 Table 4. Identification of meta
Page 468 and 469:
453 SN 614 277. The presence of the
Page 470 and 471:
455 2. Toxicological studies 2.1 Ac
Page 472 and 473:
457 treated rabbits showed slight e
Page 474 and 475:
459 still evident in the liver; how
Page 476 and 477:
461 In a 90-day feeding study, grou
Page 478 and 479:
463 per day or 800 mg/kg bw per day
Page 480 and 481:
465 The dosing solutions were prepa
Page 482 and 483:
467 mortality and morbidity. Change
Page 484 and 485:
469 2.4 Genotoxicity Pyrimethanil w
Page 486 and 487:
471 mean body‐weight gains. After
Page 488 and 489:
473 Analysis of dosing solutions in
Page 490 and 491:
475 In a 7-day feeding study, group
Page 492 and 493:
477 at 200 mg/kg bw. These clinical
Page 494 and 495:
479 s ystemic toxicity was 400 ppm
Page 496 and 497:
481 Acute toxicity Rat, LD 50 , ora
Page 498 and 499:
483 Grosshans, F. (2003) Pyrimethan
Page 500 and 501:
485 Markham, L.P. (1989d) Technical
Page 502 and 503:
ZOXAMIDE First draft prepared by I.
Page 504 and 505:
489 The excretion of radioactivity
Page 506 and 507:
491 Table 3. Mean concentration of
Page 508 and 509:
493 Table 4. Distribution of metabo
Page 510 and 511:
495 were also found in the urine, a
Page 512 and 513:
497 owing to the absence of a dose-
Page 514 and 515:
499 The NOAEL was 30 000 ppm, equiv
Page 516 and 517:
501 Table 9. Haematological finding
Page 518 and 519:
503 Table 11. Body weight, food con
Page 520 and 521:
505 daily for signs of moribundity,
Page 522 and 523:
507 Table 14 Results of studies of
Page 524 and 525:
509 phase. The study was certified
Page 526 and 527:
511 Table 16. Spleen weights and hi
Page 528 and 529:
513 FOB/motor activity assessment,
Page 530 and 531:
515 Excretion was primarily in the
Page 532 and 533:
517 days 14 to 21. Increased relati
Page 534 and 535:
519 Lowest relevant inhalation NOAE
Page 536 and 537:
521 Morrison, R.D. & Gillette, D.M.
Page 538 and 539:
ANNEX 1 Reports and other documents
Page 540 and 541:
525 31. Pesticide residues in food:
Page 542 and 543:
527 67. Pesticide residues in food
Page 544:
529 101. Pesticide residues in food
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